Comparing Simplified EEG Monitoring Tool With Standard EEG Monitoring in Patients With Acute Neurological Insult

A Validation Study to Compare Bispectral Index EEG Monitoring With Full EEG in Patients With an Acute Neurological Insult

After any acute brain injury, a primary pathophysiological response arises, enabling the brain to develop seizures and/or a status epilepticus (SE). These are frequently reported in patients admitted to the intensive care unit (ICU) with traumatic brain injury and brain injury caused by subarachnoid or intracerebral hemorrhage. Seizures can be presented without any clinical motor signs, which are then termed as nonconvulsive, and therefore remain frequently clinically unrecognized. As such, it is of great importance that these patients are diagnosed as early as possible since the increased metabolic demand and blood flow associated with an epileptic insult may further compromise the brain at risk. Thus far, continuous EEG (cEEG) is the only clinical instrument that is able to detect the development of early epileptic activity. Unfortunately, cEEG is not available in most ICUs and is labor-intensive, expensive and difficult to interpret for non-trained physicians. Therefore, a more simple and prognostic accurate EEG device is highly warranted to detect seizures in an early stage so that patients might benefit from a specific and early treatment. A validation study in comatose patients with an acute neurological insult will be conducted to provide evidence that simplified Bispectral Index EEG monitoring has the potential to detect epileptic activity as reliable as its gold standard, full EEG monitoring. Thereby, BIS EEG monitoring could possibly be used to facilitate the prognostication and management of epileptic seizures in this patient cohort which could eventually improve the clinical outcome.

Study Overview

• Status: Unknown
• Conditions: Acute Neurological Insult
• Intervention / Treatment: Device: Bispectral index (BIS) EEG monitoring

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ward Eertmans, drs.; Email: frank.jans@uhasselt.be
• Study Contact Backup: Name: Frank Jans, prof. dr.; Email: frank.jans@zol.be

Study Locations

• Belgium
  • Genk, Belgium, 3830
    • Recruiting
    • Ziekenhuis Oost-Limburg
    • Contact: Ward Eertmans, drs.; Email: ward.eertmans@uhasselt.be
    • Principal Investigator: Frank Jans, prof. dr.
    • Sub-Investigator: Ward Eertmans, drs
    • Sub-Investigator: Cathy De Deyne, prof. dr.
    • Sub-Investigator: Pascal Vanelderen, prof. dr.
    • Sub-Investigator: Willem Boer, dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients (age ≥ 18 years) admitted to the ICU with an acute neurological insult which will be sedated/ventilated (Glasgow Coma Scale (GCS) ≤ 8).
• Ability to place BIS sensors on the forehead
• Written informed consent form has to be obtained from the patient's next of kin and has to be reconfirmed if the patient regains consciousness

Exclusion Criteria:

• Age < 18 years
• Inability to place BIS sensors on the forehead (e.g. due to frontal decompression)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: study group; Patients (age ≥ 18 years) admitted to the ICU with an acute neurological insult which will be sedated/ventilated (Glasgow Coma Scale (GCS) ≤ 8).

Device: Bispectral index (BIS) EEG monitoring; The Bispectral Index (BIS) EEG monitor is a simplified EEG monitoring device which was originally designed to monitor the depth of hypnosis during general anesthesia. It does this by analyzing changes in the processed electroencephalogram (EEG) which occur with the hypnotic state and creating a measure (or index) indicative of these changes. A number between 0 and 100 is derived, with values above 70 associated with an awake state. The monitor also provides a single channel EEG, an electromyogram (EMG) and an index of signal quality (SQI), all in real time.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
A comparison between BIS derived EEG and standard full EEG	Unfiltered BIS derived EEG data from 15 minutes before or after the acquisition of a full intermittent EEG will be used to compare BIS derived EEG traces with full intermittent EEG traces. These data will be (retrospectively) analyzed by experienced neurophysiologists for the presence of seizures and/or status epilepticus.	15 minutes before or after the acquisition of standard full EEG monitoring.

Collaborators and Investigators

• Sponsor: Hasselt University
• Collaborators: Ziekenhuis Oost-Limburg
• Investigators: Principal Investigator: Frank Jans, prof. dr., Ziekenhuis Oost-Limburg, Hasselt University; Study Chair: Cathy De Deyne, prof. dr., Ziekenhuis Oost-Limburg, Hasselt University; Study Chair: Willem Boer, dr., Ziekenhuis Oost-Limburg; Study Chair: Pascal Vanelderen, prof. dr, Ziekenhuis Oost-Limburg, Hasselt University; Study Chair: Ward Eertmans, drs., Hasselt University

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Anticipated): May 1, 2018
• Study Completion (Anticipated): May 1, 2018

Study Registration Dates

• First Submitted: August 20, 2015
• First Submitted That Met QC Criteria: September 8, 2015
• First Posted (Estimate): September 10, 2015

Study Record Updates

• Last Update Posted (Actual): March 27, 2018
• Last Update Submitted That Met QC Criteria: March 24, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: BISZOL1